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503B outsourcing facilities

Software for 503B outsourcing facilities

cGMP-grade batch manufacturing, serialization, environmental monitoring, and a real quality system — for facilities producing office stock at scale.

A 503B outsourcing facility is a pharmaceutical manufacturer that happens to compound. It produces office stock in batches, holds itself to cGMP, and lives under FDA oversight. That demands batch records, environmental monitoring, serialization, and a quality system with teeth. Pharmacy Flow is built for exactly this.

cGMP operations, end to end

Batch manufacturing

Batch records with component lot capture, yield, and reconciliation — the manufacturing backbone.

Environmental monitoring

Cleanroom readings, ISO-class tracking, and excursion handling for sterile production.

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Serialization

GS1 GTIN/SGTIN serialization for unit-level traceability and recall readiness.

Quality system

Deviations, CAPA, change control, and document control with Part 11 e-signatures.

One-click recall

Trace any lot forward and back across the supply chain in seconds.

Multi-facility

Run and compare multiple sites from one platform with per-site controls.

Traceability and recall you can prove

When a batch is questioned, you need the whole genealogy — raw material lots in, finished units out, and everywhere they went — instantly. Serialization plus the event spine make recall a query, not a fire drill. See the USP <800> checklist and our compliance overview.
Producing at volume for clinics and health systems? The fulfillment engine handles high-throughput pick/pack/ship of office stock with the same traceability applied to every unit.

Frequently asked questions

Does it support cGMP batch records?+
Yes — batch manufacturing with component lot capture, yield, reconciliation, and Part 11 e-signatures on release.
How does recall work?+
Unit-level serialization plus the event log let you trace any lot forward and backward across suppliers, batches, and shipments in seconds.
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See Pharmacy Flow on your own data

A working platform, not a slide deck. Book a walkthrough and we'll show it against your pharmacy's real workflow.